Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers After Meal

Phase 1

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Harnal-D Tab.; Drug: Chong Kun Dang Tamsulosin HCl Tab.

• Registration Number: NCT03887871
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

This study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers

Detailed Description

To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.

Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Study Timeline

• Study Start: 2019-03-11
• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Primary Completion: 2019-03-22
• Study First Posted: 2019-03-25
• Study Completion: 2019-04-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Healthy subject older than 19 years men at the screening

2. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)

3. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)

4. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2

   * BMI = Weight(kg)/ Height(m)2

5. Individuals who had agreed to participate in the study

6. Individuals without mental illness history within five year prior to the screening

7. Individuals without a medical history of gastrointestinal operations that may affect drug absorption

8. Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration

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Exclusion Criteria

1. Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month

2. Individuals who had excessive drinking within the 1 month

   *Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)

3. Individuals who had taken any medication within 10 days prior to the first day of dosing

4. Individuals who were deemed to be inappropriate to participate in the study by the investigator

5. Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing

6. Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s)

7. Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)

8. Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.

9. Individuals with orthostatic hypotension

10. Individuals with severe hepatopathy

11. Individuals who had taken alpha-1 blocker

12. Individuals who had history of micturition syncope

13. Individuals with nephropathy

14. Elderly person

15. Individuals who had taken PDE5(phosphodiesterase-5) inhibitor

16. Individuals who had taken CYP3A4 inhibitor

17. Individuals who had taken antihypertensive drug(s)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference/Test	Harnal-D Tab.	1. Period 1: Harnal-D Tab. 1T 2. Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T
Reference/Test	Chong Kun Dang Tamsulosin HCl Tab.	1. Period 1: Harnal-D Tab. 1T 2. Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T
Test/Reference	Harnal-D Tab.	1. Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T 2. Period 2: Harnal-D Tab. 1T
Test/Reference	Chong Kun Dang Tamsulosin HCl Tab.	1. Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T 2. Period 2: Harnal-D Tab. 1T

Primary Outcome Measures

Name	Time	Method
AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D	Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 hours	Area under the Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood-time curve from zero to final
Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D	Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 hours	The maximum Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood sampling time t

Trial Locations

Locations (1)

Bestian Hospital; 🇰🇷 Osong, Korea, Republic of